A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00373256

Purpose

To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer

Condition	Intervention	Phase
Breast Neoplasms	Drug: Sunitinib Drug: paclitaxel Drug: bevacizumab	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel Sunitinib Sunitinib malate Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	A Phase 3 Study Of SU011248 In Combination With Paclitaxel Versus Bevacizumab With Paclitaxel In The First-Line Advanced Disease Setting In Patients Having Breast Cancer

Further study details as provided by Pfizer:

Primary Outcome Measures:

To compare the progression-free survival for patients who receive SU011248 plus paclitaxel versus bevacizumab plus paclitaxel [ Time Frame: From screening until disease progression or discontinuation of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the treatments for safety, tumor control, survival, patient reported outcomes and biomarkers [ Time Frame: From screening until disease progression or discontinuation of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	740
Study Start Date:	November 2006
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Sunitinib Sunitinib 25 mg daily by oral capsules with titration up to 37.5 mg, Drug: paclitaxel Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.
B: Active Comparator	Drug: bevacizumab Bevacizumab 10 mg/kg IV every 2 weeks. Drug: paclitaxel Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of advanced breast cancer.
Measurable disease as per RECIST (Response Evaluation Criterion) in Solid Tumors or bone-only disease.
ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.

Exclusion Criteria:

No prior treatment with cytotoxics in the advanced disease setting.
HER2/neu positive disease unless trastuzumab was previously received or is contraindicated.
Treatment with a taxane in the adjuvant setting unless disease free interval >12 months after end of treatment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373256

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Show 275 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181094
Study First Received:	September 7, 2006
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00373256
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Breast cancer, advanced, sunitinib, bevacizumab, paclitaxel, Phase 3

Study placed in the following topic categories:

Skin Diseases
Sunitinib
Paclitaxel

Breast Neoplasms
Bevacizumab
Breast Diseases

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Angiogenesis Inhibitors
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009